MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-09-26 for CVS HEALTH UPC#050428270752 953437 manufactured by Aso Llc.
[87352146]
As of 09/18/2017 the initial complaint by the customer did not indicate that an mdr would be required. However, the consumer stated on 08/22/2017 that he required treatment. Based on the information received, aso opted to file an mdr. Aso has reviewed records of biocompatibility tests.
Patient Sequence No: 1, Text Type: N, H10
[87352147]
The initial report on 07/18/2017, the customer stated that product irritated his nose, ripped his skin off and left it red and sore the next day. However, on 08/22/2017 the consumer sent a follow up report indicating that he required treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2017-00031 |
| MDR Report Key | 6893242 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-09-26 |
| Date of Report | 2017-07-18 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-07-18 |
| Date Added to Maude | 2017-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CVS HEALTH |
| Generic Name | NASAL STRIPS CLEAR MEDIUM |
| Product Code | LWF |
| Date Received | 2017-09-26 |
| Model Number | UPC#050428270752 |
| Catalog Number | 953437 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASO LLC |
| Manufacturer Address | 300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-26 |